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NCT Number: NCT04590313

Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus

A randomised, controlled trial will be performed by allocating 40 years or older patients with symptomatic hallux rigidus to arthrodesis or watchful waiting group in a ratio of 1:1. Our primary outcome will be pain during walking, assessed by the 0-10 Numeric Rating Scale (NRS) at one year after randomisation. Our secondary outcomes will be pain in rest (NRS), physical function (MOXFQ), patient satisfaction in terms of Patient-accepted Symptom State (PASS), health-related quality of life (EQ-5D-5L), activity level (The Foot and Ankle Ability Measure Sports subscale), use of analgesics or orthoses and rate of complications. Our null hypothesis is that there will be no difference between arthrodesis and watchful waiting in treatment of hallux rigidus. Our primary analysis will be done using intention-to-treat principle.

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This study is active but is not currently recruiting participants.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, 00029 HUS, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40 years or over
  • Diagnosis of hallux rigidus: Persistent pain on movement of the first MTPJ AND Osteoarthritic first MTPJ in plain X-rays
  • Duration of symptoms ≥1 year
  • Pain-NRS during walking of 4 or more on a scale 0-10 (higher is worse)
  • No substantial pain in other joints of the foot in clinical examination
  • Willingness to accept both treatment options
  • Ability to understand trial information and answer outcome assessments in Finnish
  • Signed informed consent

Exclusion criteria

  • ASA* physical status classification level III or higher
  • Patients with weak co-operation (dementia, schizophrenia, etc.)
  • Patients with neuropathy, i.e. unable to feel 10g monofilament pressure in less than 8 out of 10 standard testing sites
  • Active bacterial infection or ulcer of the lower limb
  • Diabetes mellitus with insulin treatment
  • Diabetes mellitus and GHb-A1C >64 mmol/mol (regardless of treatment)
  • History of rheumatoid arthritis, gout or other inflammatory arthritis of the foot
  • Hallux valgus angle >15° in weight-bearing X-ray
  • Hallux varus in weight-bearing X-ray
  • Large bone cysts in X-ray probably requiring bone grafting in surgery
  • Pain in passive manipulation of ipsilateral first toe IP joint
  • Patients with severe circulatory disorder of the lower limb: absence of palpable pulses in the foot (both dorsalis pedis artery and tibialis posterior artery)
  • History of surgery of the foot in question
  • Neuropathic pain of the foot in question (i.e., use of neuropathic analgesics)
  • Activity limiting symptoms from an earlier fracture or ligament injury of the foot
  • Patient is not willing to accept the operation within the planned time limits (3 to 12 weeks post-randomisation)

Treatment and study plan

Arthrodesis

Procedure

MTPJ I arthrodesis

Primary outcomes

  1. Pain during walking in Numerical Rating Scale (NRS)

    Time frame: 1 year after randomisation

    scale 0-10; 0=no pain, 10=worst pain

Secondary outcomes

  1. Pain during rest in Numerical Rating Scale (NRS)

    Time frame: 6 months, 1year, 2 years, 5 years

    scale 0-10; 0=no pain, 10=worst pain

  2. Pain during walking in Numerical Rating Scale (NRS)

    Time frame: 6 months, 2 years, 5 years

    scale 0-10; 0=no pain, 10=worst pain

  3. Patient Related Outcome

    Time frame: 6 months, 1year, 2 years, 5 years

    MOXFQ-score, Scale 0-100

  4. Patient reported quality of life

    Time frame: 6 months, 1year, 2 years, 5 years

    EQ-5D-5L, Scale 0-100

  5. Complications

    Time frame: 6 months, 1year, 2 years, 5 years

    Number of minor and major adversary effects

  6. Patient Acceptable Symptom State

    Time frame: 6 months, 1year, 2 years, 5 years

    Percentage of patients with acceptable symptom state (PASS)

  7. Patients physical activity

    Time frame: 6 months, 1year, 2 years, 5 years

    FAAM Sports Subscale, Scale 0-100

  8. Use of analgesics and orthoses

    Time frame: 6 months, 1year, 2 years, 5 years

    The use of analgesics: 1) no use of analgesics or less frequent than weekly, 2) weekly use of analgesics, 3) daily use of NSAIDS or paracetamol, 4) daily use of opioids.

    The use of orthoses: yes/no

Sponsors and collaborators

Lead sponsor

Hospital District of Helsinki and Uusimaa

Other

Registry information

Official study title

Treatment of Hallux Rigidus (HARD): A Prospective, Randomised, Controlled Trial of Arthrodesis Versus Watchful Waiting in the Treatment of Hallux Rigidus

Acronym: HARD

Important dates

Study start
2021
Primary completion
2025
Study completion
2029
First posted
Oct 19, 2020
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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